Long-term Follow-up of Subjects Treated With CAR T Cells

Primary outcomes

1. Overall Survival

   Time frame: 1 month

   defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

2. Overall Survival

   Time frame: 6 months

   defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

3. Overall Survival

   Time frame: 12 months

   defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

4. Overall Survival

   Time frame: 24 months

   defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive

5. Progresison Free Survival

   Time frame: 1 month

   PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

6. Progresison Free Survival

   Time frame: 6 months

   PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

7. Progresison Free Survival

   Time frame: 12 months

   PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

8. Progresison Free Survival

   Time frame: 24 months

   PFS is defined as the number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

9. New incidence or exacerbation of a pre-existing neurologic disorder or prior rheumatologic or other autoimmune disorder

   Time frame: Up to 15 Years

   An annual physical exam will be conducted for surveillance of manifestations indicative of oncoretroviral diseases.

10. New incidence of a hematologic disorder

    Time frame: up to 15 years

    An annual physical exam will be conducted for surveillance of manifestations indicative of oncoretroviral diseases.

11. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v 5.0

    Time frame: up to 15 years

    NCI Common Terminology Criteria for Adverse Events (CTCAE)

12. Vector-derived RCL

    Time frame: baseline and in 3 months, 6 months, and annually up to 15 years

    Archiving of samples for potential detection of vector-derived RCL. RCL testing will be monitored at the central RCL lab (Indiana University) by a suitable qPCR assay for detection of the lentiviral vector (VSV-g DNA).

13. Assessment of CAR T cells persistence by VCN in peripheral blood

    Time frame: baseline and in 3 months, 6 months, every 6 months up to 5 years, and annually up to 15 years

    VCN will be performed in DNA from whole blood to monitor for persistence of vector sequence

14. Progression-free Survival

    Time frame: From post-CAR T cells infusion date until date of first documented disease progression or date of death from any cause, assessed up to 15 years post treatment

    The number of days from the day of CAR T cells treatment to the first documented disease progression or date of death, whichever occurs first. Patients who are lost to follow up without a known date of progression or death due to any cause will be censored in the analysis at the date of their last available tumor assessment.

15. Overall Survival

    Time frame: From post-CAR T cells infusion date until documented date of death from any cause, assessed post treatment every 6 months through 5 years and then annually up to 15 years

    The time from post-CAR T cells infusion to the date of death.